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Clinical Trials/NCT04314817
NCT04314817CompletedNot Applicable

Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Groupe Hospitalier Pitie-Salpetriere1 site in 1 country1,000 target enrollmentStarted: March 17, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
Renal failure

Study Overview

Brief Summary

The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • all patients treated for Covid-19

Exclusion Criteria

  • Chronology not compatible between the drug and the toxicity

Arms & Interventions

Patients treated for Covid-19

Intervention: Any drug used to treat Covid-19 (Drug)

Outcomes

Primary Outcomes

Renal failure

Time Frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms

Secondary Outcomes

  • Heart failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • EKG disturbance(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Hepatic failure(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Anemia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Leucopenia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Vascular disease(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Toxidermia(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Osteoarticular adverse event(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Death(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Acute respiratory distress syndrome(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)
  • Pulmonary embolism or pulmonary hypertension(Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020)

Investigators

Sponsor
Groupe Hospitalier Pitie-Salpetriere
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lee S Nguyen

Principal Investigator

Groupe Hospitalier Pitie-Salpetriere

Study Sites (1)

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